Stabilizer for a medical delivery system

This application is a continuation of U.S. application Ser. No. 17/090,167, filed on Nov. 5, 2020, which claims the benefit of U.S. Provisional Application No. 62/931,687, filed on Nov. 6, 2019, the disclosures of which are incorporated herein by reference in their entireties.

The disclosed subject matter is directed to medical devices for endovascular, percutaneous or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair. More particularly, the present disclosure relates to repair of valves of the heart and venous valves.

Surgical repair of bodily tissues can involve tissue approximation and fastening of such tissues in the approximated arrangement. When repairing valves, tissue approximation includes coapting the leaflets of the valve in a therapeutic arrangement which can then be maintained by fastening or fixing the leaflets. Such coaptation can be used to treat regurgitation, which commonly occurs in the mitral valve and in the tricuspid valve.

Mitral valve regurgitation is characterized by retrograde flow from the left ventricle of the heart through an incompetent mitral valve into the left atrium. During a normal cycle of heart contraction (systole), the mitral valve acts as a check valve to prevent flow of oxygenated blood from the left ventricle back into the left atrium. Instead, as the left ventricle contracts the oxygenated blood is pumped from the left ventricle into the aorta through the aortic valve. Regurgitation of the mitral valve can significantly decrease the pumping efficiency of the heart, placing the patient at risk of severe, progressive heart failure.

Mitral valve regurgitation can result from a number of different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the valve chordae connecting the leaflets to the papillary muscles, the papillary muscles, or the left ventricular wall can be damaged or otherwise dysfunctional. Commonly, the valve annulus can be damaged, dilated, or weakened, limiting the ability of the mitral valve to close adequately against the high pressures of the left ventricle.

Treatments for mitral valve regurgitation can involve valve replacement or repair including leaflet and annulus remodeling, the latter generally referred to as valve annuloplasty. Another technique for mitral valve repair, which can be referred to as the “bow-tie” or “edge-to-edge” technique, can involve suturing adjacent segments of the opposed valve leaflets together. Preferably, devices and systems for mitral valve repair can be utilized without open chest access, and, rather, can be capable of being performed endovascularly, i.e., delivering fixation devices (e.g., a valve repair clip) using delivery systems advanced to the heart from a point in the patient's vasculature remote from the heart. Furthermore, such delivery systems should allow for repositioning and optional removal of the fixation devices prior to fixation to provide proper placement. Stabilizer devices, such as a support frame, can be provided to support one or more portions of the delivery systems that remain external to the patient during repair procedures. Stabilizers are configured to maintain relative positions of various components of the delivery systems. During edge-to-edge repair procedures, however, the user (e.g., the medical professional performing the procedure) must be able to advance and retract various portions (or components) of the delivery system relative to one another. Typically, the user must manually lift and physically move the components relative to one another. The user also must be able to advance or retract the entire delivery system relative the patient's body. To do this, the user typically lifts and moves the entire system, including the stabilizer, relative the patient's body. As such, there remains a need for a stabilizer or system capable of simplified and controlled movement of related delivery systems and components. Such devices and systems likewise can be useful for repair of tissues in the body other than heart valves.

The purpose and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the systems and methods particularly pointed out in the written description and claims hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter is directed to a stabilizer for a medical delivery system, as well as a system including the same.

In accordance with the disclosed subject matter, a stabilizer for a medical delivery system is provided, wherein the medical delivery system has at least two portions translatable relative each other. The stabilizer includes a base and a sled coupled to the base. The sled includes a distal arm including a distal attachment for receiving a first portion of the medical delivery system, and a proximal arm including a proximal attachment for receiving a second portion of the medical delivery system. The sled is translatable relative to the base and the proximal attachment is translatable relative to the proximal arm.

The stabilizer can include a sled drive mechanism coupled to the base and the sled. The sled drive mechanism can include a control knob to control movement of the sled drive mechanism to translate the sled relative the base. The sled drive mechanism can be a sled lead screw. The sled lead screw can be coupled to the sled by a threaded boss. Additionally or alternatively, the stabilizer can include an attachment drive mechanism coupled to the proximal arm and the proximal attachment. The attachment drive mechanism can include a control knob to control movement of the proximal attachment to translate the proximal attachment relative the proximal arm. The attachment drive mechanism can be an attachment lead screw. The attachment lead screw can be coupled to proximal arm by at least one threaded bearing block.

In accordance with the disclosed subject matter, the sled can be releasably coupled to the base. The base can include a flexible tab to releasably couple the base and the sled. The flexible tab can provide a distal stop to restrict translation of the sled relative the base.

At least one of the sled and the base can include indicia for position of the sled relative the base. The indicia can include a series of graduation marks disposed at equal intervals. The proximal arm can include a zero-reference marker for positioning the proximal attachment.

In accordance with the disclosed subject matter, a medical delivery system is provided. The medical delivery system can include an outer guide catheter, an inner guide catheter, an outer-guide-catheter handle, and inner-guide-catheter handle, and a stabilizer. The outer guide catheter has a distal end portion and a proximal end portion, and the inner guide catheter has a distal end portion and a proximal end portion. The outer-guide-catheter handle is coupled to the proximal end portion of the outer guide catheter and the inner-guide-catheter handle is coupled to the proximal end portion of the inner guide catheter. The stabilizer includes a base and a sled. The sled includes an outer-guide-catheter arm including an outer-guide-catheter attachment for receiving the outer-guide-catheter handle and an inner-guide-catheter arm including an inner-guide-catheter attachment for receiving the inner-guide-catheter handle. The sled is translatable relative to the base and the inner-guide-catheter attachment can be translatable relative to the inner-guide-catheter arm.

In accordance with the disclosed subject matter the medical delivery system can include a sled drive mechanism coupled to the base and the sled. The sled drive mechanism can include a control knob to control movement of the sled drive mechanism to translate the sled relative the base. The sled drive mechanism can be a sled lead screw. The sled lead screw can be coupled to the sled by a threaded boss. Additionally or alternatively, the medical delivery system can include an attachment drive mechanism coupled to the inner-guide-catheter arm and the inner-guide-catheter attachment. The attachment drive mechanism can include a control knob to control movement of the inner-guide-catheter attachment to translate the inner-guide-catheter attachment relative the inner-guide-catheter arm. The attachment drive mechanism can be an attachment lead screw. The attachment lead screw can be coupled to inner-guide-catheter arm by at least one threaded bearing block.

In accordance with the disclosed subject matter, the sled can be releasably coupled to the base. The base can include a flexible tab to releasably couple the base and the sled. The flexible tab can provide a distal stop to restrict translation of the sled relative the base.

At least one of the sled and the base can include indicia for position of the sled relative the base. The indicia can include a series of graduation marks disposed at equal intervals. The inner-guide-catheter arm can include a zero-reference marker for positioning the inner-guide-catheter attachment.

In accordance with the disclosed subject matter, the medical delivery system can include a delivery catheter having a distal end portion and a proximal end portion. The medical delivery system can include a fixation device coupled to the distal end portion of the delivery catheter. Additionally or alternatively the medical delivery system can include a delivery-catheter handle coupled to the proximal end portion of the delivery catheter.

Reference will now be made in detail to the various exemplary embodiments of the disclosed subject matter, exemplary embodiments of which are illustrated in the accompanying drawings.

The stabilizer of the disclosed subject matter can be used for edge-to-edge transcatheter valve repair for patients having various conditions, including regurgitant mitral valves or tricuspid valves. Although described with respect to edge-to-edge repair, the stabilizer of the disclosed subject matter can be used with a wide variety of suitable transcatheter delivery systems. Transcatheter (e.g., trans-septal) edge-to-edge valve repair has been established using a fixation device, such as the MitraClip Transcatheter Mitral Valve Repair device. These fixation devices generally are configured to capture and secure opposing native leaflets using two types of leaflet contacting elements. The first element is a sub-valvular arm (also known as a distal element or fixation element) to contact the ventricular side of a native leaflet to be grasped. With the arm positioned underneath to stabilize the native leaflet in a beating heart, a second gripping element (also known as a proximal element) can be lowered or moved into contact with the atrial side of the native leaflet to capture the leaflet therebetween. Once each opposing leaflet is captured by a respective arm and gripper element, the fixation device can be closed by moving the arms toward a center of the fixation device such that the leaflets are brought into coaptation, which results in a reduction in valvular regurgitation during ventricular systole. Furthermore, a covering can be provided on the arms and/or gripper elements to facilitate tissue ingrowth with the captured leaflets. Such fixation devices can be delivered to the mitral valve using a delivery system. The delivery system can include multiple steerable catheter components that can be steered independently and moved relative one another to facilitate proper alignment of the fixation device with the leaflets prior to leaflet capture. Alignment can also be facilitated by moving the entire delivery system relative to the patient.

Additional details of exemplary fixation devices and delivery systems in accordance with the disclosed subject matter are set forth below. Furthermore, various patents and published applications disclose additional details of such fixation devices and delivery systems and related operations, for example, U.S. Pat. No. 7,226,467 to Lucatero et al., U.S. Pat. No. 7,563,267 to Goldfarb et al., U.S. Pat. No. 7,655,015 to Goldfarb et al., U.S. Pat. No. 7,736,388 to Goldfarb et al., U.S. Pat. No. 7,811,296 to Goldfarb et al., U.S. Pat. No. 8,057,493 to Goldfarb et al., U.S. Pat. No. 8,303,608 to Goldfarb et al., U.S. Pat. No. 8,500,761 to Goldfarb et al., U.S. Pat. No. 8,734,505 to Goldfarb et al., U.S. Pat. No. 8,740,920 to Goldfarb et al., U.S. Pat. No. 9,510,829 to Goldfarb et al., U.S. Pat. No. 7,635,329 to Goldfarb et al., U.S. Pat. No. 8,945,177 to Dell et al., U.S. Pat. No. 9,011,468 to Ketai et al., U.S. Patent Application Publication No. 2017/0042546 to Goldfarb et al., U.S. Patent Application Publication No. 2017/0239048 to Goldfarb et al., U.S. Patent Application Publication No. 2018/0325671 to Abunassar et al., the entirety of the contents of each of these patents and published applications is incorporated herein by reference.

Generally, and as set forth in greater detail below, the disclosed subject matter provided herein includes a stabilizer for a medical delivery system. The stabilizer of the disclosed subject matter can provide the user the ability to move various components of the medical delivery system as a whole without manually lifting and moving the structure. Also, the stabilizer of the disclosed subject matter provides the user with more precision and control when moving various portions of the delivery system relative to one another and when moving the entire delivery system relative to the patient.

In accordance with the disclosed subject matter, a stabilizer is provided including a base and a sled coupled to the base. The sled includes a distal arm including a distal attachment for receiving a first portion of the medical delivery system, and a proximal arm including a proximal attachment for receiving a second portion of the medical delivery system. The sled is translatable relative to the base and the proximal attachment is translatable relative to the proximal arm.

1 4 FIGS.- 10 11 FIGS.- 9 11 FIGS.- 2000 2000 2100 2200 2100 2100 2200 2210 2211 1056 2220 2221 1057 304 Referring now tofor purpose of illustration and not limitation, a stabilizerfor a medical delivery system (also referred to herein as “delivery system”) is disclosed herein. The stabilizerincludes a baseand sled. The basecan have a planar shape for positioning on or against a flat surface, such as a table or benchtop. Alternatively, the basecan be contoured to rest on a patient during use. The sledincludes a distal armwhich can include a distal attachmentfor receiving a first portion of a delivery system (for example, an outer guide catheter handle, see). The sled also includes a proximal armwhich can include a proximal attachmentfor receiving a second portion of a delivery system (for example, an inner guide catheter handleand/or a delivery catheter handle, see).

2211 2221 2221 Distal attachmentcan include a yoke or similar structure which can include set screws and gripping elements or similar structure for receiving the first portion of the delivery system. The proximal attachmentcan be a block or similar structure, including a recess configured to receive the second portion of the delivery system. The proximal attachmentcan include set screws and gripping elements or similar structure for receiving the second portion of the delivery system.

2200 2100 2200 2100 2200 2230 2230 2231 2230 2230 2232 2200 2233 2233 2200 2233 2200 2232 2233 2232 2100 2234 2231 2232 2200 2100 2232 2235 2231 2200 2200 2100 1 2 FIGS.and The sledas disclosed herein is translatable relative to the base. For example, the sledcan be moved axially or longitudinally along the basewithin a guide or track or the like. Referring to, for purpose of illustration and not limitation, the sledcan include a sled drive mechanism, which can be hydraulic, pneumatic, or otherwise mechanical. The sled drive mechanismcan include a sled control knob, however, sled drive mechanismcan be controlled by any suitable control system, for example, a slide, trigger, handle, or digital control. As embodied herein, the sled drive mechanismcan include a sled lead screwand the sledcan include a threaded boss, although the components can be reversed if desired. The threaded bosscan be attached to the sled, or the threaded bosscan be unitary with the sled. The sled lead screwcan be received within the threaded boss. The sled lead screwcan be rotatably coupled to the base, for example, by at least one bearing block. When the sled control knobis rotated, the sled lead screwcan rotate, which can translate the sledrelative to the base. In this manner, the sledcan be translated distally or proximally along axisdepending on the direction of rotation of the sled control knob. Because the entire medical delivery system can be coupled to the sled, as described further below, translation of the sledrelative to the basecan cause the medical delivery system to translate relative to the based, and thus patient.

2221 2220 2200 2220 2200 2221 2240 2240 2241 2240 2240 2242 2242 2220 2244 2242 2220 2244 2244 2221 2242 2243 2241 2242 2221 2220 2221 2245 2241 2221 2200 2241 2210 2200 2221 2200 2221 2200 1057 304 1056 1 3 FIGS.and In accordance with the disclosed subject matter, the proximal attachmentseparately is translatable relative to the proximal arm(and therefore relative to the sledbecause the proximal armand the sledare fixed relative one another). Referring to, for purpose of illustration and not limitation, the proximal attachmentcan include an attachment drive mechanism, which can be hydraulic, pneumatic, or otherwise mechanical. The attachment drive mechanismcan include an attachment control knob, however, attachment drive mechanismcan be controlled by any suitable control system, for example, a slide, trigger, handle, or digital control. As embodied herein, the attachment drive mechanismcan include an attachment lead screw. The attachment lead screwcan be rotatably coupled to the proximal arm(and therefore the sled), for example, by at least one threaded bearing block. For example, and not limitation, the attachment lead screwembodied herein is attached to the proximal armby two threaded bearing blocksA,B. The proximal attachmentcan receive the attachment lead screw, for example, within a threaded portion. When the attachment control knobis rotated, the attachment lead screwcan rotate, which can translate the proximal attachmentrelative to the proximal arm. In this manner, the proximal attachmentcan be translated distally or proximally along axisdepending on the direction of rotation of the attachment control knob. Because the second portion of the medical delivery system is attached to the proximal attachment(which moves relative to the sledwhen the attachment control knobis rotated) and the first portion of the medical delivery system is attached to the distal arm(which remains stationary relative to the sled), translation of the proximal attachmentrelative to the sledcan cause the second portion of the medical delivery system to translate relative to the first portion of the medical delivery system. For example, and as described further below, translation of the proximal attachmentrelative to the sledcan move the inner guide catheter handleand the delivery catheter handlerelative to the outer guide catheter handle.

2230 2240 2230 2240 Although this disclosure describes specific designs for the sled drive mechanismand attachment drive mechanism, this disclosure contemplates any suitable drive mechanisms. For example, the sled drive mechanismand/or attachment drive mechanismcan include worm gears, rack and pinion, pistons, solenoids or the like.

2200 2100 2250 2200 2100 2250 2251 2200 2100 2252 2251 2200 2252 2100 4 FIG. In accordance with the disclosed subject matter, at least one of the sledand the basecan include indiciafor positioning of the sledrelative the base. For example, the indiciacan include a series of graduation marks. The graduation marks can be disposed at equal intervals, such as 1 mm. The other of the sledand basecan include an indicator arrowor the like.shows, for purpose of illustration and not limitation, graduation marksdisposed at 1 mm intervals on the sledand an indicator arrowdisposed on the base. The indicia thus can provide the operator with an indication of the relative movement or position of the delivery system relative the patient, for example, within a left atrium.

2220 2222 2221 2222 104 1000 2221 2241 1057 304 1056 Additionally or alternatively, the proximal armcan include a zero-reference marker. This can provide the user with a reference location for connecting the inner delivery catheter to the proximal attachment. In accordance with the disclosed subject matter, the markercan assist the user in positioning the tip of the fixation devicerelative to the outer guide catheter. The user can then advance the proximal attachmentusing the attachment control knob, which can provide enhanced control of translation of the inner guide catheter handleand the delivery catheter handlerelative to the outer guide catheter handle.

2000 2000 2100 2200 2100 2200 2110 2110 2111 2111 2100 2111 2200 2100 2200 2111 2112 2200 2111 2200 2100 4 FIG. In accordance with the disclosed subject matter, the stabilizercan be a reusable device. That is, the same stabilizercan be made of suitable materials to be sterilized and used for multiple surgical procedures. The base andand the sledcan be releasably couple, which can allow for easier cleaning and sterilization between uses. Referring to, for purpose of illustration and not limitation, the baseand the sledcan be provided with a disassembly system. The disassembly systemcan include a flexible tab. For example, the flexible tabcan be provided on the base. The flexible tabcan allow the sledto slide into the base, for example, by flexing downwardly. When the baseand sledare coupled together, the flexible tabcan return to a relaxed position and can provide a distal stopfor translation of the sledin the distal direction. For disassembly, the flex tabcan be manually flex downwardly, and the sledcan slide distally off the base.

5 6 FIGS.and 104 171 171 104 174 108 171 110 171 Referring tofor purpose illustration and not limitation, an exemplary fixation devicefor fixation of native leaflets of a heart valve is disclosed herein. The fixation device as embodied herein can include a central assembly. The central assemblycan include various central components for operation and release of the fixation devicefor example, a coupling memberas described in the disclosures of the patents and applications incorporated by reference herein. The fixation device as depicted can include at least one armmoveably coupled to the central assembly. As shown, the fixation device can further include a second armmoveably coupled to the central assembly.

6 FIG. 6 FIG. 108 110 148 150 108 110 108 110 With reference to, and further in accordance with the disclosed subject matter, each arm,can be rotatable about a respective axis point,between closed, open and inverted positions, as well as any position therebetween. Furthermore, the arms,can be selected from a range of suitable lengths, wherein the appropriate length can be selected by the physician or health care provided, for example after inspection of a patient. For purpose of comparison, a first length of each arm,is depicted inin solid lines, and a second longer length of each arm of the disclosed subject matter is depicted in dashed lines. The arms in solid lines can be an entirely separate arm with a different length as compared to the arm in dashed lines.

7 7 FIGS.A-C 7 FIG.A 7 7 FIGS.B andC 7 FIG.B 7 FIG.C 104 As depicted herein in, various positions of the fixation deviceare depicted for purpose of illustration and not limitation. Elongated arms are illustrated in dashed lines for comparison to shorter arms (in solid lines). In, the fixation device is in the closed position, wherein the arms are positioned axially in alignment, e.g., vertically or nearly vertically as shown.illustrate the arms positioned with an angle A between each other. In, angle A is about 10 degrees, and in, angle A is about 60 degrees. As disclosed herein, the fixation device is in the closed position when angle A is about 30 or less degrees. Although not depicted, the arms can continue to open until angle A exceeds 180 degrees, e.g., inverted.

104 116 108 The fixation devicecan further include at least one gripping elementmoveable relative to the at least one armto capture native leaflet therebetween. In accordance with the disclosed subject matter, each arm can be configured to define or have a trough aligned along the longitudinal axis. The trough can have a width sized greater than a width of the gripper element so as to receive the gripper element therein.

118 110 116 118 152 116 118 152 116 118 152 152 The fixation device can further include a second gripping elementmoveable relative to the second armto capture a second native leaflet therebetween. Further, in accordance with the disclosed subject matter, the at least one gripping element,can have at least one friction elementalong a length thereof. As embodied herein, each gripping element,can include a plurality of friction elements, which can be disposed in rows. For example, each gripping elementandcan have a least four rows of friction elements. The friction elementscan allow for improved tissue engagement during leaflet capture. This gripping element design can increase the assurance that single device leaflet detachment will not occur during or after a procedure. To adjust the fixation device after an initial leaflet capture, the arms can be opened, the gripping element can be raised vertically, and issue can disengage from the fixation device, facilitating re-grasp and capture.

116 118 108 110 116 118 108 110 116 118 116 118 As further embodied herein, each gripping element,can be biased toward each respective arm,. Prior to leaflet capture, each gripping element,can be moved inwardly toward a longitudinal center of the device (e.g., away from each respective arm,) and held with the aid of one or more gripper element lines (not shown), which can be in the form of sutures, wire, nitinol wires, rods, cables, polymeric lines, or other suitable structures. The sutures can be operatively connected with the gripping elements,in a variety of ways, such as by being threaded though loops disposed on gripping elements,.

104 168 168 108 110 170 170 176 64 176 64 176 176 64 174 64 176 104 176 168 108 110 168 108 110 9 FIG. Fixation devicecan further include two link members or legs, and as embodied herein, each leghas a first end rotatably joined with one of the arms,and a second end rotatably joined with a base. Basecan be operatively connected with a studwhich can be operatively attached to an actuator rodof the delivery system (see). In some embodiments, the studcan be threaded such that the actuator rodcan attach to the studby a screw-type action. Further, the connection point between the studand the actuator rodcan be disposed within the coupling member. However, the actuator rodand studcan be operatively connected by any mechanism which is releasable to allow the fixation deviceto be detached. The studcan be axially extendable and retractable to move the base and therefore the legs, which can rotate the arms,between closed, open and inverted positions. Immobilization of the stud, such as by a locking mechanism, can hold the legsin place and therefore lock the arms,in a desired position. Further details are disclosed in the patents and published applications incorporated by reference herein.

8 8 FIGS.A-B 8 FIG.B 8 FIG.B 104 108 110 222 222 222 As previously noted, a native leaflet can be captured between each arm and respective gripping element. Each arm can then be moved toward its closed position. In this matter, adjacent leaflets can further be captured between the arms in the closed position. For example, and for illustration only,show the fixation devicedepicted with arms,at an angle A of about 10 to 30 degrees with two leaflets captured therebetween, wherein each leaflet is captured between an arm and a respective gripping element (gripping elements not shown). As illustrated in, a contact patch areadepicted in dashed lines and is defined by the area of tissue captured between the arms. The contact patch areacan depict a tissue-to-tissue contact patch area defined by area of a leaflet in contact with a counterpart leaflet. As previously noted,depicts the contact patch areawhen the fixation device is oriented at angle A of about 10 to 30 degrees.

9 FIG. 300 300 300 302 322 324 304 322 324 324 320 104 324 64 64 104 104 108 110 304 300 308 312 310 314 316 304 306 1057 Referring tofor purpose of illustration and not limitation, an exemplary delivery deviceis provided for delivery of a fixation device as disclosed. That is, the delivery devicecan be used to introduce and position a fixation device as described above. The delivery devicecan include a shaft, having a proximal endand a distal end, and a handleattached to the proximal end. A fixation device (not shown) can be removably coupleable to the distal endfor delivery to a site within the body, for example, the mitral valve. Thus, extending from the distal endis a coupling structurefor coupling with a fixation device. Also extending from the distal endis an actuator rod. The actuator rodis connectable with the fixation deviceand can act to manipulate the fixation device, for example, opening and closing the arms,. Handleof the delivery deviceis shown, including main body, proximal element line handle, the lock line handle, the actuator rod controland the actuator rod handle, among other features. The handleis supported by the support basewhich is connected to handle.

10 FIG. 3 1 1 1 1000 1014 1016 1020 1024 1026 1020 1000 1090 1056 1056 1020 1016 1026 1000 1020 Referring to, for purpose of illustration and not limitation, medical delivery systemincluding a steerable guide systemis provided. The steerable guide systemcan include multiple steerable catheter components. For example, and not limitation, steerable guide systemcan include an outer guide catheter, having a proximal endand a distal end, and an inner guide catheter, having a proximal endand a distal end, wherein the inner guide catheteris positioned coaxially within the outer guide catheter, as shown. In addition, a hemostatic valvecan be disposed within handleor external to handleas shown to provide leak-free sealing with or without the inner guide catheterin place. The distal ends,of catheter,, respectively, are sized to be passable to a body cavity, typically through a body lumen such as a vascular lumen.

1000 1020 1056 1057 1000 1020 1056 1014 1000 1057 1024 1020 1020 1056 1000 Manipulation of the guide catheter,can be achieved with the use of handles,attached to the proximal ends of the catheter,. As shown, handleis attached to the proximal endof outer guide catheterand handleis attached to the proximal endof inner guide catheter. Inner guide catheteris inserted through handleand is positioned coaxially within outer guide catheter.

300 1057 1020 1000 300 302 322 324 304 322 104 324 The delivery cathetercan be inserted though handleand can be positioned coaxially within inner guide catheterand outer guide catheter. The delivery catheterincludes a shaft, having a proximal endand a distal end, and a handleattached to the proximal end. A fixation devicecan be removably coupled to the distal endfor deliver to a site within the patient

1000 1020 1016 1026 1000 1016 1020 1026 3 1020 1000 1026 1020 300 1000 1020 300 104 The outer guide catheterand/or the inner guide cathetercan be precurved and/or have steering mechanisms to position the distal ends,in desired directions. Precurvature or steering of the outer guide cathetercan direct the distal endin a first direction to create a primary curve while precurvature and/or steering of the inner guide cathetercan direct distal endin a second direction, different from the first, to create a secondary curve. Together, the primary and secondary curves can form a compound curve. Furthermore, advancement of the entire interventional systemor the inner guide catheter(relative to the outer guide catheter) can further direct the distal endof the inner guide cathetertoward a desired position. Advancement of the delivery catheterthrough the coaxial guide catheters,can guide the delivery catheterthrough the compound curve toward a desired direction, usually in a direction which will position the fixation devicein a desired location in the body.

11 FIG. 11 FIG. 3 1056 1057 1 1056 1057 1300 1300 1000 1020 1300 1300 1000 1020 2210 2211 2221 2000 2211 1056 2221 1057 a b a b is an enlarged view of the controls of a medical delivery systemin accordance with the disclosed subject matter. Handles,of the steerable guide systemare shown. Each handle,includes a set of steering knobs,, as shown. Manipulation of guide catheterandcan be achieved with the use of the steering knobs,attached to the proximal ends of the catheters,. Further details of exemplary delivery systems are disclosed in the patents and published applications incorporated by reference herein. Alternative handles and/or controls likewise are contemplated in accordance with the disclosed subject matter. Distal arm, distal attachmentand proximal attachmentof stabilizerare shown schematically in. Particularly, distal attachmentcan receive handleand proximal attachmentcan receive handle.

104 104 104 108 110 108 110 116 118 116 118 108 110 104 104 104 104 In accordance with the disclosed subject matter, the fixation devicecan be adapted for repair of a heart valve, such as a mitral valve, using an antegrade approach from a patient's left atrium. The fixation devicecan be introduced in a femoral vein of a patient and advanced through the inferior vena cava into the heart and, for mitral valve repair, across a penetration in the interatrial septum. The fixation devicecan be advanced through the mitral valve from the left atrium to the left ventricle. The arms,can be oriented to be perpendicular to a line of coaptation and positioned with the arms,contacting the ventricular surface of the valve leaflets, thereby grasping the leaflets. The gripping elements,can remain on the atrial side of the valve leaflets with the leaflets disposed between the gripping elements,and the arms,. The fixation devicecan be manipulated as desired to reposition the device such that the leaflets are properly grasped at a desired location. Repositioning can be performed with the fixation devicein the open position. As embodied herein, regurgitation of the valve can also be checked while the fixation deviceis in the open position. If regurgitation is not satisfactorily reduced, the fixation devicecan be repositioned and regurgitation checked again until the desired results are achieved.

1 4 9 11 FIGS.-and- 2000 3 2211 1056 1014 1000 2221 1057 1024 1020 304 322 300 1016 1000 1016 1000 1056 2211 1026 1020 324 300 104 1000 1026 1020 1057 2221 2222 1026 1020 104 1000 104 1056 1057 3 2230 300 104 1000 2240 With reference tofor purpose of illustration and not limitation, during use, stabilizercan support delivery system. Distal attachmentcan receive (and support) handlecoupled to the proximal endof outer guide catheter. Proximal attachmentcan receive (and support) handlecoupled to the proximal endof inner guide catheteras well as handlecoupled to the proximal endof delivery catheter. During a mitral valve repair procedure, for example, the distal endof the outer guide cathetercan be advanced through a blood vessels of the patient (for example the femoral vein and inferior vena cava) to the right atrium of the heart, across the septum, and into the left atrium of the heart. Once the distal endof the outer guide catheteris placed in the left atrium, handlecan then be coupled to distal attachment. The distal endof inner guide cathetertogether with the distal endof delivery catheterand fixation devicecoupled thereto, can be advanced through the outer guide catheterto left atrium of the heart. Once the distal endof the inner guide catheteris advance to the left atrium, handlecan be coupled to proximal attachment. Markercan assist the user in initially positioning the tip of the distal endof inner guide catheter(and therefore fixation device) relative to the outer guide catheter. Once the fixation devicehas been delivered to the left atrium, it can be positioned in the desired location using handles,to steer the distal end of the delivery system(as described above), advancing the entire delivery system relative the patient by operating sled drive mechanism, and/or advancing the inner guide catheter (and delivery catheterand fixation device) relative the outer guide catheterby operating attachment drive mechanism.

104 116 118 108 110 116 118 108 110 108 110 108 110 104 300 14 Once the fixation devicehas been positioned in a desired location relative to the valve leaflets, the leaflets can then be captured between the gripping elements,and the arms,. As embodied herein, the gripping elements,can be lowered toward the arms,to dispose the leaflets therebetween. The arms,can be closed to an angle selectable by the user and locked to the prevent the arms,from moving toward an open position. The fixation devicecan then be detached from the distal end of the delivery catheter. After detachment, the repair of the leaflets or tissue can be observed by non-invasive visualization techniques, such as echocardiography, to ensure the desired outcome. If the repair is not desired, the fixation devicecan be retrieved. If the repair is satisfactory, the gripper element lines can be disconnected, and the fixation device can be released for implantation.

In view of the above and in accordance with the disclosed subject matter, a system is provided including an outer guide catheter, an inner guide catheter, an outer-guide-catheter handle, an inner-guide-catheter handle, and a stabilizer. The outer guide catheter includes a distal end portion and a proximal end portion, and the inner guide catheter includes a distal end portion and a proximal end portion. The outer-guide-catheter handle is coupled to the proximal end portion of the outer guide catheter and the inner-guide catheter handle is coupled to the proximal end portion of the inner guide catheter. The stabilizer includes a base and a sled coupled to the base. The sled includes an outer-guide-catheter arm including an outer-guide-catheter attachment for receiving the outer-guide-catheter handle, and an inner-guide-catheter arm including an inner-guide-catheter attachment for receiving the inner-guide-catheter handle. The sled is translatable relative to the base and the inner-guide-catheter attachment is translatable relative to the inner-guide-catheter arm. Additional features as described above can be incorporated in the system.

While the embodiments disclosed herein utilize a push-to-open, pull-to-close mechanism for opening and closing arms it should be understood that other suitable mechanisms can be used, such as a pull-to-open, push-to-close mechanism. A closure bias can be included, for example using a compliant mechanism such as a linear spring, helical spring, or leaf spring. Other actuation elements can be used for deployment of the gripper elements.

While the disclosed subject matter is described herein in terms of certain preferred embodiments for purpose of illustration and not limitation, those skilled in the art will recognize that various modifications and improvements can be made to the disclosed subject matter without departing from the scope thereof. Moreover, although individual features of one embodiment of the disclosed subject matter can be discussed herein or shown in the drawings of one embodiment and not in other embodiments, it should be readily apparent that individual features of one embodiment can be combined with one or more features of another embodiment or features from a plurality of embodiments.

In addition to the specific embodiments claimed below, the disclosed subject matter is also directed to other embodiments having any other possible combination of the dependent features claimed below and those disclosed above. As such, the particular features presented in the dependent claims and disclosed above can be combined with each other in other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to those embodiments disclosed.

It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents.